The European Commission has approved AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

Will Alex Azar’s experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?

The Tamper Evident Labeller from LSS Labelling Systems Scandinavia is compliant with the European Falsified Medicines Directive.

Pharma Team Up has launched Poseidon, an integrated ocean freight program, to address the disconnect between pharma companies and their logistics providers.

The company announced 15 new collaborations focused on addressing unmet medical needs, including using artificial intelligence in the early detection of Alzheimer’s disease, saliva testing for throat cancers, and using the microbiome to treat sleep disorders.

AptarGroup’s Landfill Free Certification program addresses the issue of waste production from pharmaceutical manufacturing processes by prompting its facilities to reduce and reuse operation waste.

ERT’s Target My Hives, an app for patients and physicians treating chronic urticaria, more commonly known as hives, aims to improve patient outcomes by integrating physicians and patient associations and facilitating communal support.

The companies aim to develop a potential zinc finger protein transcription factor-based gene therapy for treating Lou Gehrig’s disease.

The companies aim to discover and develop locked nucleic acid oligonucleotides as orally available therapies for treating inflammatory bowel diseases.

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.

FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.

The company is voluntarily recalling product because of glass particles found in vials.

The companies will collaborate on the development of vaccines to expand GeoVax’s cancer immunotherapy program.

The IFPAC annual meeting on advancing the understanding and control of manufacturing processes using process analytical technology will be held Feb. 11-14, 2018.

The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.

The agency published draft guidance on good practices for submitting abbreviated new drug applications.

PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance.

Bio/pharma professionals manage expectations amid industry uncertainty.

Will business decisions and drug pricing policies help or hinder science and drug approval advances in 2018?

Brexit-related challenges cast shadows on prospects for the European bio/pharma market in 2018, but optimism may let some sun shine through.

The companies have entered an agreement involving assay development and the manufacturing of kits supporting biomarker research programs.

The biotechnology company has filed for FDA approval of a new plasma manufacturing facility in Covington, GA, to support its immunology franchise.

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.

Mallinckrodt has agreed to acquire biopharmaceutical company Sucampo Pharmaceuticals for $18 per share, or a transaction value of approximately $1.2 billion.

Roche has agreed to acquire Ignyta, an oncology company specializing in precision medicines, in an all-cash transaction valued at $1.7 billion.